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Clinical study on effect of fecal microbiota transplantation on glycolipid metabolism in obese type 2 diabetes patients

Clinical study on effect of fecal microbiota transplantation on glycolipid metabolism in obese type 2 diabetes patients

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100043020
Enrollment
Unknown
Registered
2021-02-04
Start date
2021-06-01
Completion date
Unknown
Last updated
2021-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

type 2 diabetes mellitus

Interventions

Newly diagnosed obese T2DM with FMT:Fecal microbiota transplantation
Newly diagnosed obese T2DM with FMT+diet management:Fecal microbiota transplantation+diet management
Newly diagnosed obese T2DM with diet management:Diet management
Treated diagnosed obese T2DM with FMT:Fecal microbiota transplantation
Normal control group:No

Sponsors

Changzhou 2nd People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: 1. Meet the 2019 American Diabetes Association (ADA) diagnosis of type 2 diabetes (T2DM); 2. Diabetes course <=6 years; 3. BMI 28-45kg/m2; 4. Volunteer to participate in the trial and sign an informed consent form; 5. patients aged 18-50 years old.

Exclusion criteria

Exclusion criteria: 1. Acute and chronic infectious diseases, gastrointestinal diseases, severe heart insufficiency, severe liver and kidney insufficiency and other diseases or complications; 2. People with other gastrointestinal diseases that may affect drug absorption; 3. Patients with malignant tumors in the past 2 years; 4. Patients who cannot tolerate gastroscopy; 5. Pregnant and lactating women; 6. People with allergies; 7. Patients who have used weight-loss drugs in the past year; 8. Patients using other hormone therapy in the past 3 months; 9. Patients who have used antibiotics or probiotics in the past 3 months; 10. Cardiovascular and cerebrovascular diseases occurred newly in the past 3 months; 11. Participate in other clinical trials during the same period.

Design outcomes

Primary

MeasureTime frame
HbA1c;

Secondary

MeasureTime frame
Blood lipid;Intra-abdominal fat;Fecal microbiota;Bile acid;Fasting blood glucose;Free fatty acid;Liver fat content;Blood glucose fluctuations;Islet function;Short chain fatty acids;Inflammatory factors;

Countries

China

Contacts

Public ContactShi Li

Changzhou 2nd People's Hospital

shili1204@sina.com+86 13861193196

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026